Dynabeads MyOne SILANE are monosized, magnetic beads that bind to nucleic acids (NAs) in biological samples.
By applying a magnetic field, the Dynabeads-NA complex can be separated and the NAs concentrated for diagnostic analysis such as the detection of methylated DNA of the SEPT9 gene, the biomarker that is targeted by Epi proColon2.0.
According to Epigenomics, compared to the first generation test system, Epi proColon 2.0 requires fewer components and handling steps and can reach results within 8 hours which makes it to automate on IVD automation solutions.
Epigenomics Product Development senior vice president Uwe Staub said by including these crucial components into their assay along with some other modifications, they are able to improve clinical performance and shorten the overall time to result allowing for testing of higher volumes of samples.
Epigenomics plans to conduct analytical and clinical validation studies in the second half of 2011.
The company expects to submit a pre-market approval application (PMA) for Epi proColon 2.0 to the US Food and Drug administration before year-end 2011.
